Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT07179328
Phase
PHASE1
Status
Recruiting
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Conditions

  • Brain Tumor Adult
  • Brain Tumor, Primary
  • GBM
  • Glioblastoma Multiforme (GBM)
  • Glioblastoma Multiforme Glioma
  • Glioblastoma Multiforme of Brain
  • Glioma
  • HGG

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Focused Ultrasound Next Generation Dome Helmet — DEVICE
    The Next Generation Dome Helmet (FUS NG) is a non-invasive, MRI-guided focused ultrasound system developed at Sunnybrook Research Institute. It is used to disrupt the blood-brain barrier (BBB) in patients with glioblastoma during the maintenance phase of temozolomide (TMZ) therapy. The device allows targeted BBB opening using a fixed transducer array and intravenous DEFINITY® contrast.
  • Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension — DRUG
    DEFINITY® Perflutren Injectable Microbubbles is an ultrasound contrast imaging agent that will be used for blood brain barrier opening during focused ultrasound. These microbubbles will be injected during the focused ultrasound procedure.

Study Details

The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard "Stupp protocol". Participants will: * Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy. * Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption. * Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening. * Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response. * Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.

Key Dates

First listed
Sep 17, 2025
Start date
Jun 4, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Focused Ultrasound BBB Disruption Using the Next Generation Dome Helmet and Definity
    Participants in this single-arm study will undergo repeated sessions (up to 6 cycles spaced 4-6 weeks apart) of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) during the maintenance phase of standard-of-care temozolomide (TMZ) chemotherapy. At the time of each FUS session, participants will receive their prescribed standard of care TMZ dose, as well as an intravenous injection of DEFINITY® ultrasound contrast agent that enables targeted BBB opening. Each session will be guided by MRI, and imaging will be used to assess the extent of BBB disruption. Clinical and safety assessments, blood sampling for biomarker analysis, and follow-up imaging will be conducted throughout the study period.

Primary Outcome Measure

Safety of Focused Ultrasound-Mediated BBB Disruption [ Time Frame: Participants will be evaluated at baseline, every 8 weeks during the first year, and every 12 weeks during the second year. ]

Central Contacts

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